Help to reduce the use of hormone therapy and analgesics and improve the quality of life for women with the least complicated drugs
Design
This study is a clinical trial study with a control group, with parallel groups, three blinded, randomized, that will use the chamomile and chamomile capsules as the intervention group and lactose capsules for placebo. These capsules have the same shape and size at a dose of 500 mg and are quite similar to each other, with a sample size of 183 patients.
Settings and conduct
The place of research is the Faghihi and Zainabiyyeh hospitals and the Motahari clinic. Patient will be randomly assigned into three intervention groups, the researcher, patient, and analyzer are blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.Women with fibroid disease confirmed 2.Women who are willing to cooperate and have submitted their written consent 3. Not taking any hormone medication 4.The patient is not involved in any other disease 5. not be pregnant 6. not be lactating 7. Not allergic to chamomile and chamomile and mefenamic acid 8. No history of gastrointestinal, liver, brain and kidney disease and coagulation disorders 9.Body Mass Index 19-29
10. Age range 20-49 years 11.No history of prolonged constipation
Exclusion criteria:1.Allergic reaction to the drug 2. People with asthma 3.People taking anticoagulants 4. People taking benzodiazepine drugs5. People who drink alcohol 6.People who become pregnant during the study
7. Disease exacerbation during the study when the patient requires hormone therapy 8. People who are sensitive to lactose
Intervention groups
The three intervention groups in this study consisted of 500 mg chamomile, sumac and placebo capsules, each administered three times daily
Main outcome variables
Pain; Bleeding; Urinary Frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200113046115N1
Registration date:2020-03-21, 1399/01/02
Registration timing:prospective
Last update:2020-03-21, 1399/01/02
Update count:0
Registration date
2020-03-21, 1399/01/02
Registrant information
Name
maryam jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3425 0884
Email address
jafari_ma@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Matricaria Chamomile and Rhus Coriaria on Some Uterine Fibroma Symptoms in Women with fibroid diseases
Public title
The Effect of Matricaria Chamomile and Rhus Coriaria on some Uterine Fibroma Symptoms in Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with Fibroid Disease Confirmed by a Gynecologist
Women who are willing to Cooperate and Submit Their Written Consent
Not taking any Hormonal Medication
The patient is not involved in any other diseases, including thyroid disease, endometriosis, adenomyosis and malignancies, etc. (Based on patient records)
Don't be pregnant
Don't be lactating
Not Allergic to Chamomile and Sumac and Mefenamic Acid
No History of Gastrointestinal, liver, Brain and Kidney Disease and Coagulation disorders
Body Mass Index 19-29
Age range 20-49 years
No history of prolonged constipation
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
183
Randomization (investigator's opinion)
Randomized
Randomization description
Divide the block into three groups A, B, C and each letter is randomly assigned to the sumac, chamomile, and placebo group. The letters are then grouped into 6 (1: ABC, 2: ACB, 3: BAC, 4: BCA, 5: CBA, 6: CAB) and A number is randomly selected from 1 to 6, indicating the order of allocation of the first three individuals in the groups. Again, 1 to 6 numbers are selected at random. The order of assignment of individuals to groups is specified at each time
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the capsules of the same size and color in dark color packages will be prepared by the pharmacology unit of Shiraz University of Medical Sciences.Medicines with specific codes that only the pharmacist is aware of and The researcher is the prescriber and the participant is unaware.The data analyzer is also uninformed. In this study, only the pharmacist is aware of the type of medication
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of shiraz university of medical science
Street address
Central building of Shiraz university of Medical Science ,Zand Ave,Across Palestin Street
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2019-12-31, 1398/10/10
Ethics committee reference number
IR.SUMS.REC.1398.1199
Health conditions studied
1
Description of health condition studied
Uterine Fibroma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Moderate to severe pain
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Pain measurement by using visual analogue scale
2
Description
Bleeding includes menorrhagia and menometrorrhagia
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Using a pictorial blood assessment chart, patient with the bleeding score higher than 100 will study The pre-study and post-study scores will be compared
3
Description
Frequent urination more than 7 times a day
Timepoint
Before intervention and 2 months after intervention
Method of measurement
urination will be entered into the study more than 7 times a day and the number of urination before and after the intervention will be questioned and recorded and compared by the patient
Secondary outcomes
empty
Intervention groups
1
Description
500 mg Matricaria chamomile capsule standardized by Barij Essence Company and packaged by Shiraz University of Medical Sciences Pharmacology Unit and medication duration three times daily for two menstrual cycles for the first seven days of menstruation.
Category
Treatment - Drugs
2
Description
The 500 mg Sumac Rus Coriaria capsule is standardized and packaged by the Shiraz University of Medical Sciences Pharmacology Unit and is administered three times daily during the first seven menstrual cycles of the menstrual cycle.
Category
Treatment - Drugs
3
Description
Control group: 500 mg placebo capsule containing cellulose powder packaged by Shiraz University of Medical Sciences pharmacology unit and drug administration three times daily during two menstrual cycles for the first seven days of menstruation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi hospital
Full name of responsible person
Dr.Mohammad Vahid Joraat
Street address
Zand St, Shiraz، Fars Province
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
Faghihihsp@sums.ac.ir
2
Recruitment center
Name of recruitment center
Zeiynabiyyeh haspital
Full name of responsible person
Dr.Navid Omidifar
Street address
Zeynabiyeh Blv، Shiraz، Fars Province
City
Shiraz
Province
Fars
Postal code
715381311
Phone
+98 71 3726 6811
Email
Zeinabhp@sums.ac.ir
3
Recruitment center
Name of recruitment center
Motahari clinic
Full name of responsible person
Dr.Mani Ramzi
Street address
Next to Namazi Hospital,Karim Khan Zand Blvd, Shiraz, Fars Province
City
Shiraz
Province
Fars
Postal code
71473771438
Phone
+98 71 3612 1000
Email
Motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Central Building of Shiraz University of Medical Science, Zand Street, Shiraz, Fars province
City
Shiraz
Province
Fars
Postal code
71345- 1978
Phone
+98 71 1212 2633
Fax
+98 71 1212 2430
Email
info@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marziyeh Akbarzadeh
Position
Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Midwifery and Nursing, Namazi Square
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4254
Email
AKBARZADEHMARZIEH@YAHOO.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Jafari
Position
Student of Master of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
6 Block, Eram Dormitory, Eram sq
City
Shiraz
Province
Fars
Postal code
111111111
Phone
+98 77 3425 0884
Email
maryam.jafari9170@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Jafari
Position
Student of Master of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
6 Block, Eram dormitory, Eram sq
City
Shiraz
Province
Fars
Postal code
111111111
Phone
+98 77 3425 0884
Email
maryam.jafari9170@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After analyzing the data and after Identifying people, part of the data will be available as a pdf file
When the data will become available and for how long
3 Month After Finish of Study
To whom data/document is available
Researchers are working in university centers
Under which criteria data/document could be used
No data can be used under any circumstances
From where data/document is obtainable
Referring to Professor Marziyeh Akbarzadeh
What processes are involved for a request to access data/document
Visit the Faculty of Nursing and Midwifery of Professor Akbarzadeh's office